cellular data connectivity The value proposition is easy to see and the advantages can be well worth the investment.
Connected medical devices are shaking up the industry. Look at just about any home healthcare device in the last few years: chances are, you’ll find some sort of wireless chipset inside to radio information to the internet for telemedicine purposes.

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medtech skills gapDespite a high number of university or college graduates looking for entry level work in the tech industry, companies still report difficulty in hiring [1]. This is in part due to a medtech skills gap between entry level work and university training. Industry involvement in academia has the power to address this issue. Who better to teach skills within academia than those who have them?

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medical commercialization lessons learnedAs part of our 20th anniversary celebrations, we asked our experts to share the biggest lesson they have learned in medical device commercialization.  Several themes emerged: budgets, production readiness, usability, and what to tackle first.  Here are their top 13 lessons learned in no particular order.

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fastening 3D printed componentsRapid Prototyping – Augmented

Fastening 3D printed components presents a frustrating challenge. While we can print threads directly as a feature of parts, the resolution of the thread and the strength of the threads make printing seldom viable. We can bond parts, but that loses replaceability or maintenance. Self-tapping screws can work effectively as well, but often the materials used in 3D printing can crack under installation stresses. Fortunately, there is another option: installing metal inserts. In this blog I discuss a variety of commonly used threaded inserts.

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Reduce medical device program risksTesting underpins the entire medical device development process. It provides the tangible evidence of device efficacy and safety.  Testing generally begins with a reasonably ad hoc approach in Phase Zero for proof of concept and then shifts to a more formalized testing strategy to address safety and efficacy. At this point in time, product definition has matured to include the identification of specifications for the device to be tested. The following is a brief overview of a systematic approach to device testing, from laying the groundwork to writing the final report.

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Leveraging TalentI would like to take us all back to high school Biology for a moment to remember the concept of emergent properties. These properties only come out when individual parts start interacting with each other in any given system. Take common salt for example. The fact that it tastes salty does not mean that the sodium and chlorine which make up salt also taste salty. Saltiness is an emergent property. Often, so are the problems we encounter when developing medical devices. 

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Program ArchitectureMedical device commercialization projects often require the Project or Program Manager to also wear the hat  of “Program Architect.” 

“When it is obvious that the goals cannot be reached, don’t adjust the goals, adjust the action steps.” Confucius
What’s your product vision? And what is the mission that you will undertake to get there? These are the big questions that program and project managers concern themselves with throughout commercialization projects.  This is also precisely where the art of program architecture comes into play.  Much like a Systems Architect puts together building blocks to meet the technical goals of the product, Program Architects assemble building blocks to meet the strategic goals of the product.

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medical devices in Regenerative MedicineI recently spoke with Michael May, President and Chief Executive Officer of CCRM, a Canadian not-for-profit that develops technologies and launches new companies by supporting both academic and industry activities in the field of regenerative medicine, including cell and gene therapy. Our conversation focused on the intersection of medical devices in Regenerative Medicine.

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Health Canada’s Action Plan on Medical Devices
In early 2019 Health Canada released more specifics of their Action Plan on Medical Devices. The Action Plan is intended to reinforce Health Canada’s commitment to ensuring that Canadians have access to safe and effective medical devices based upon the most up to date information. It has a three-prong strategy involving:
i) improve regulatory rigor for medical device path to market,
ii) strengthen post-marketing monitoring and follow-up, and
iii) increase transparency to the public.

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